VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors

Required: PD-L1 (CD274) positive (≥1% of tumor cells or ≥1% of stroma)

For RMS efficacy cohort, at least 8 of 17 patients must have PD-L1(+) tumor. PD-L1(+) status defined as staining on ≥1% of tumor cells or ≥1% of stroma.

Must have received: any prior therapy

Relapsed or refractory solid tumor after at least one prior course of therapy.

Cannot have received: allogeneic stem cell or solid organ transplantation

Prior allogeneic stem cell or solid organ transplantation

Cannot have received: CD137 agonist

Prior treatment with CD137 agonists

Cannot have received: anti-PD-1 therapy

Prior treatment with anti-PD-1 therapeutic antibodies

Cannot have received: anti-PD-L1 therapy

Prior treatment with anti-PD-L1 therapeutic antibodies

Cannot have received: systemic immunostimulatory agents (interferon, interleukin 2)

Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment

Cannot have received: irinotecan (irinotecan)

Exception: Patients who have received irinotecan and did not progress while on this medication are eligible.

Subjects must not have previously progressed while receiving regimens that include irinotecan

Cannot have received: temozolomide (temozolomide)

Exception: Patients who have received temozolomide and did not progress while on this medication are eligible.

Subjects must not have previously progressed while receiving regimens that include temozolomide